Esophageal CancerPhase 2NCT07733830
Comparing ICI Followed By CCRT And CCRT Followed By Immunotherapy In Unresectable LA-ESCC
A Phase 2 study testing Adebrelimab, Nab paclitaxel and Carboplatin in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 7 sites in China.
Trial summary
A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups. Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- Adebrelimab, Nab paclitaxel and Carboplatin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesChina
- Study dates
- 31 Jul 2026to 31 Dec 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteered to participate, cooperated with follow-up visits, documented informed consent;
- Aged 18 -75 years, both male and female;
- Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC); clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery);
- Measurable and/or unmeasurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST1.1) and the Japanese Classification of Esophageal Cancer (12th Edition: Part II);
- Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);
- ECOG performance status 0 or 1;
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- Provide fresh or archived tumour tissue samples within 6 months (fresh samples preferred) for biomarker analysis (e.g.PD-L1). Sample types are formalin-fixed, paraffin-embedded [FFPE] tumour tissue blocks or at least 5 unstained, 3-5 μm thick FFPE tumour tissue sections;
- Expected survival ≥ 3 months;
- Adequate hematologic function, defined as ANC ≥1500/μl, platelet count ≥100,000/μl and hemoglobin count ≥9.0 g/dl or ≥5.6 mmol/l; Adequate renal function, defined as creatinine ≤1.5× ULN or measured or calculated creatinine clearance ≥60 mL/min for those with creatinine levels >1.5× ULN (Calculated from the Cockcroft-Gault formula); Adequate hepatic function, defined as total bilirubin ≤1.5× ULN and ALT/AST/AKP levels ≤2.5× ULN and albumin ≥2.8 g/dl; Adequate coagulation function, defined as INR ≤1.5× ULN and APTT≤1.5× ULN unless the patient is receiving anticoagulant therapy as long as INR is within the therapeutic range;
- Women of childbearing potential with a negative urine pregnancy test within 3 days before the first administration of the investigational drugs.
Who cannot join
- Surgery for esophageal cancer;
- Esophageal fistulae due to infiltration of the primary tumour;
- Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
- Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
- Major surgery or severe trauma within 4 weeks prior to first use of study drug;
- Uncontrollable pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
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- Received or receiving any of the following treatments in the past:
- Anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy or targeted therapy;
- Participation in a study of an investigational agent or device within 4 weeks before the first dose of study treatment;
- Systemic treatment with corticosteroids (>10 mg prednisone equivalent dose per day) or other immunosuppressive agents is required for 2 weeks before the first dose of study treatment(except for the use of corticosteroids for local inflammation of the oesophagus and for the prevention of allergy and nausea and vomiting). Other special circumstances need to be communicated to the sponsor.Inhaled or topical steroids and adrenocorticotropic hormone replacement at doses >10mg/day prednisone efficacy dose are permitted if the patient does not have active autoimmune disease;
- Received an anti-tumour vaccine or received a live vaccine within 4 weeks before the first dose of study treatment;
- Any active autoimmune disease or history of autoimmune disease (e.g., interstitial pneumonitis, uveitis, enteritis, hepatitis, pituitary gland inflammation, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism);Except for patients with vitiligo or those who had asthma or allergies in childhood but did not need any intervention as adults; patients with autoimmune-mediated hypothyroidism treated with stable doses of thyroid replacement hormone and type I diabetes mellitus treated with stable doses of insulin may be included;
- Diagnosis of immunodeficiency, including positive HIV test,other acquired/congenital immunodeficiency diseases, organ transplantation and allogeneic bone marrow transplantation;
- Diagnosis of uncontrolled cardiac clinical symptoms or disease such as a.NYHA II or above heart failure b.unstable angina c.myocardial infarction within 1 year d.clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention;
- Severe infections (CTCAE > Grade 2), such as severe pneumonia requiring hospitalisation, bacteraemia, infectious co-morbidities, etc., within 4 weeks before the first use of study treatment; Baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks before the first use of study treatment, except for prophylactic antibiotic use;
- History of interstitial lung disease or non-infectious pneumonia, or pulmonary insufficiency ≥ grade 3 as confirmed by pulmonary function tests;
- Active tuberculosis infection detected by history or CT examination, or history of active tuberculosis infection within 1 year before enrollment or more than 1 year previously without regular treatment;
- Presence of active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection);
- Presence of abnormal sodium, potassium, and calcium laboratory test values greater than Grade 1 within 2 weeks prior to randomisation that do not improve with treatment;
- Known hypersensitivity to large protein preparations, or to any of the components of nab-paclitaxel or carboplatin or to any of the components used within their preparations;
- Any other malignant tumor was diagnosed before the first use of the study drug, except for malignant tumors with a low risk of metastasis and death (5-year survival rate > 90%), such as well-treated basal cell or squamous cell skin cancer or cervical carcinoma in situ;
- Pregnant or lactating patients;
- After the researchers' judgment, the subjects have other factors that may force them to terminate the study halfway, such as suffering from other serious diseases (including mental disorders) that require combined treatment, having other serious diseases recently (such as myocardial infarction, cerebrovascular accident) that are considered to have a high risk of recurrence, severely abnormal laboratory test values, family or social factors. Situations that may affect the safety of the subjects or the collection of experimental data.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality
Yong Yu
- Recruiting
National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
Wenyang Liu, MD
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan
Qifeng Wang, MD, wangqifeng@scszlyy.org.cn
- Recruiting
Liaoning Cancer Hospital
Shenyang, Liaoning
Yanli Qu
- Recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi
Jianzhong Cao
- Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Wencheng Zhang, MD, 02223340123, wczhang@tmu.edu.cn
- Recruiting
Henan Cancer Hospital
Zhengzhou, Hanan
Xiao Liu
About this study
Official title: Comparing Induced Chemoimmunotherapy Followed By Concurrent Chemoradiotherapy And Concurrent Chemoradiotherapy Followed By Immunotherapy In Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Randomized, Phase II Trial
A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups.
Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles.
Read more
Arm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles.
This study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.
- Conditions
- Esophageal Cancer
- Being tested
- Adebrelimab, Nab paclitaxel, Carboplatin, radiation
- Keywords
- Induction Immunochemotherapy, Adebrelimab, Esophageal Squamous Cell Carcinoma
- Medical subject headings
- Esophageal Neoplasms, Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdebrelimabDrug
anti-PD-L1 immunotherapy
Nab paclitaxelDrug
chemotherapy
CarboplatinDrug
chemotherapy
radiationRadiation
radiation
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Experimental | Induction Immunochemotherapy + CRT
1. Induction immunochemotherapy:
Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22.
2. Concurrent chemoradiotherapy:
Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f.
3. Immunotherapy maintenance:
Adebrelimab：1200mg, IV，q3w, until PD or for a maximum of 15 cycles. Receives: Drug: Adebrelimab; Drug: Nab paclitaxel; Drug: Carboplatin; Radiation: radiation |
| Arm B | Experimental | CRT + Immunotherapy
1. Concurrent chemoradiotherapy:
Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f.
2. Immunotherapy maintenance:
Adebrelimab：1200mg, IV，q3w, until PD or for a maximum of 17 cycles. Receives: Drug: Adebrelimab; Drug: Nab paclitaxel; Drug: Carboplatin; Radiation: radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Two-year follow-up from the date of randomization to the date of disease progression or last follow-up.
Measured: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Secondary outcomes (6)
Overall survival
Two-year follow-up from the enrollment to the date of death from any cause or date of last follow-up.
Measured: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months.
Overall response rate
The percentage of the total number of subjects achieving complete response (CR) and partial response (PR) among the total number of cases with evaluable efficacy.
Measured: Up to 24 months
Duration of Response
From the date of first CR/PR to the date of first progressive Disease (PD).
Measured: From date of first CR/PR to the date of first PD according to RECIST criteria and Japanese classification of esophageal cancer (12th edition), assessed up to 24 months.
Treatment-related adverse events
Incidence of treatment-related adverse events as assessed by CTCAE.
Measured: From date of randomization until the date of last follow-up, assessed up to 12 months.
Severe adverse events
Incidence of severe adverse events as assessed by CTCAE.
Measured: From date of randomization until the date of last follow-up, assessed up to 12 months.
Quality of life
Quality of life evaluated by EORCT QLQ-C30 and EORCT-OES18 scale.
Measured: From date of randomization until the date of last follow-up, assessed up to 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start31 Jul 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wencheng Zhang, MD, Principal investigator, Tianjin Medical University Cancer Institute and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733830
- Sponsor's protocol ID
- E20260838
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Induced Chemoimmunotherapy Followed By Concurrent Chemoradiotherapy And Concurrent Chemoradiotherapy Followed By Immunotherapy In Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma: A Multicenter, Randomized, Phase II Trial
- ClinicalTrials.gov ID
- NCT07733830
- Acronym / sponsor ID
- E20260838
- Conditions
- Esophageal Cancer
- Keywords
- Induction Immunochemotherapy, Adebrelimab, Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Study start
- 31 Jul 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 120 patients with unresectable, locally advanced esophageal squamous cell carcinoma patients will be enrolled in this study and randomly divided into two groups.
Arm A: After 2 cycles of induction adebrelimab plus chemotherapy, patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f), and adebrelimab will maintain to PD or for a maximum of 15 cycles.
Arm B: Patients will be treated with concurrent chemoradiotherapy (50.4Gy/1.8Gy/28f) and adebrelimab will maintain to PD or for a maximum of 17 cycles.
This study will compare the efficacy of immunotherapy in the induction and maintenance phases of radiotherapy, optimize more precise treatment plans, and potentially further increase the survival of ESCC patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A | Experimental | Drug: Adebrelimab, Drug: Nab paclitaxel, Drug: Carboplatin, Radiation: radiationInduction Immunochemotherapy + CRT 1. Induction immunochemotherapy: Nab-paclitaxel：220mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Adebrelimab：1200mg, IV，d1, d22. 2. Concurrent chemoradiotherapy: Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f. 3. Immunotherapy maintenance: Adebrelimab：1200mg, IV，q3w, until PD or for a maximum of 15 cycles. |
| Arm B | Experimental | Drug: Adebrelimab, Drug: Nab paclitaxel, Drug: Carboplatin, Radiation: radiationCRT + Immunotherapy 1. Concurrent chemoradiotherapy: Nab-paclitaxel：175mg/m2，IV，d1，d22; Carboplatin：AUC=5，IV，d1，d22; Radiotherapy：50.4Gy/1.8Gy/28f. 2. Immunotherapy maintenance: Adebrelimab：1200mg, IV，q3w, until PD or for a maximum of 17 cycles. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Volunteered to participate, cooperated with follow-up visits, documented informed consent;
- Aged 18 -75 years, both male and female;
- Histologically confirmed cT1N2-3M0 or cT2-4bN0-3M0 or cT1-4bN0-3M1( supraclavicular lymph node metastasis) locally advanced ESCC (8th AJCC); clinically staged as II-IVb inoperable locally advanced ESCC (including non-resectable, or with contraindications to or refusal of surgery);
- Measurable and/or unmeasurable lesions as defined by the criteria for evaluating the efficacy of solid tumors (RECIST1.1) and the Japanese Classification of Esophageal Cancer (12th Edition: Part II);
- Haven't received any previous systemic anti-tumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecularly targeted drug therapy, immunotherapy, biologic therapy, topical therapy and other investigational therapeutic agents);
Key exclusion criteria (23 listed)
- Surgery for esophageal cancer;
- Esophageal fistulae due to infiltration of the primary tumour;
- Risk of gastrointestinal bleeding, oesophageal fistula or oesophageal perforation
- Poor nutritional status, weight loss of ≥10% in the previous 2 months, with no significant improvement after nutritional intervention;
- Major surgery or severe trauma within 4 weeks prior to first use of study drug;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adebrelimabanti-PD-L1 immunotherapy | Drug | Arm A, Arm B |
| Nab paclitaxelchemotherapy | Drug | Arm A, Arm B |
| Carboplatinchemotherapy | Drug | Arm A, Arm B |
| radiationradiation | Radiation | Arm A, Arm B |
Primary outcome
Progression-free survival
Time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.
Two-year follow-up from the date of randomization to the date of disease progression or last follow-up.
6 secondary outcomes
Overall survival
Time frame: From date of randomization until the date of death from any cause or the date of last follow-up, whichever came first, assessed up to 24 months.
Overall response rate
Time frame: Up to 24 months
Duration of Response
Time frame: From date of first CR/PR to the date of first PD according to RECIST criteria and Japanese classification of esophageal cancer (12th edition), assessed up to 24 months.
Treatment-related adverse events
Time frame: From date of randomization until the date of last follow-up, assessed up to 12 months.
Severe adverse events
Time frame: From date of randomization until the date of last follow-up, assessed up to 12 months.
Quality of life
Time frame: From date of randomization until the date of last follow-up, assessed up to 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wencheng Zhang, MD principal investigator
Tianjin Medical University Cancer Institute and Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adebrelimab, Nab paclitaxel and Carboplatin in people with Esophageal Cancer, run by Tianjin Medical University Cancer Institute and Hospital at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wencheng Zhang, MD (02223340123 ext. 1121, wczhang@tmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From date of randomization until the date of death from any cause or the date of first documented disease progression whichever came first, assessed up to 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.